The medtech indus­try called on EU pol­i­cy­mak­ers to with­draw the pro­posed AI Lia­bil­i­ty Direc­tive. Indus­try groups, includ­ing MedTech Europe and 11 oth­er trade asso­ci­a­tions, argue that the direc­tive could intro­duce unnec­es­sary legal com­plex­i­ty and sti­fle invest­ment in AI inno­va­tion. They point to the Draghi report on EU com­pet­i­tive­ness, which rec­om­mends a stream­lined legal frame­work to main­tain the EU’s com­pet­i­tive edge.

These indus­try rep­re­sen­ta­tives note that the EU is already work­ing with sev­er­al leg­isla­tive mea­sures that affect AI — such as the AI Act, the Gen­er­al Date Pro­tec­tion Reg­u­la­tion (GDPR), the Cyber Resilience Act and oth­ers — as well as spe­cif­ic reg­u­la­tions for the medtech sec­tor like the med­ical devices and in vit­ro diag­nos­tic med­ical devices reg­u­la­tion. They con­tend that many nation­al lia­bil­i­ty frame­works already address AI, par­tic­u­lar­ly in con­sumer pro­tec­tion, so adding a new direc­tive might be redundant.

The asso­ci­a­tions fur­ther argue that the impact of exist­ing reg­u­la­tions, such as the AI Act and GDPR, has yet to be ful­ly eval­u­at­ed. They believe that the revised Prod­uct Lia­bil­i­ty Direc­tive — which extends lia­bil­i­ty for defec­tive prod­ucts to include soft­ware and AI — will pro­vide the nec­es­sary legal frame­work with­out the added bur­den of anoth­er direc­tive. In their view, intro­duc­ing the AI Lia­bil­i­ty Direc­tive now could increase reg­u­la­to­ry bur­dens and ulti­mate­ly harm EU com­pet­i­tive­ness by deter­ring investment.

It seems that the EU Com­mis­sion even­tu­al­ly shares these con­cerns: On Feb­ru­ary 11, 2025, it put the AI Lia­bil­i­ty Direc­tive on the list of pro­pos­als it intends to withdraw. 

Source: Medtech Insight (an Infor­ma product)

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